This invention relates to an improved transferset for vials and other medical containers which may be attached to a conventional vial having an elastomeric stopper or other closure for transferring fluid under sterile conditions between a vial or other container and a second container such as a syringe. The collar portion of the transferset is preferably formed of a polymer which may be permanently deformed radially to secure the transferset to the container, yet sufficiently rigid to retain its shape following deformation and resist creep.
It is conventional to store medicament such as drugs in a sealed vial or other container for later use. Such medicaments may be in a dry or powdered form to increase the shelf life of the drugs and reduce inventory space. Such dry or powdered drugs are generally stored in a sealed vial and reconstituted in liquid form for administration to a patient by adding a diluent or solvent. Alternatively, the drug may be in liquid or even gaseous form. A conventional vial for storing medicament generally includes an open end, a radial rim portion surrounding the open end and a reduced diameter neck portion adjacent the rim portion. The vial is conventionally sealed with an elastomeric stopper or closure which generally includes a generally tubular portion or annular rib inserted into the neck of the vial and a generally planar rim portion which overlies the vial rim. The stopper is normally secured to the vial with a thin malleable metal cap, such as aluminum. The aluminum cap includes a tubular portion which surrounds the rim portions of the stopper and vial, an inwardly projecting annular rim portion which overlies the rim portion of the stopper and a distal end portion which is crimped or deformed radially into the vial neck beneath the vial rim portion. Because aluminum is malleable, the collar accommodates the buildup of tolerances of the dimensions of the stopper and vial rim. The dimensions and tolerances of standard vials and stoppers are set by the International Standards Organization (ISO).
The radial portion of the aluminum cap which overlies the stopper rim portion may be closed, in which case the aluminum cap is removed by xe2x80x9cpeelingxe2x80x9d the aluminum cap from the vial. A pre-slit tab located in the middle area is provided which overlies the vial rim, permitting the cap to be torn from the top and peeled from the vial prior to use. This embodiment of an aluminum cap has several disadvantages. First, the tearing of the metal cap creates sharp edges which may cut or damage sterile gloves and cut the person administering the drug, thereby exposing both the healthcare worker and the patient to disease and contamination of the drug. Second, the tearing of the aluminum cap generates metal particles which may also contaminate the drug. The dangers associated with the tearing of an aluminum cap has been solved in part by adding a xe2x80x9cflip-offxe2x80x9d plastic cap. In one such embodiment, the aluminum collar includes a central opening and a shallow plastic cup-shaped cap is received over the aluminum collar having a central projecting riveting portion which is received and secured in the central opening of the aluminum collar. The plastic cap is then removed by forcing the flip-off cap away from the aluminum collar, which tears an annular serrated portion surrounding the central opening and exposes an opening in the collar for receipt of a hypodermic needle or the like. This embodiment reduces but does not eliminate the possibility of tearing the sterile gloves of the healthcare worker. More importantly, however, aluminum dust is still created which may contaminate the medicament. It is also important to note that metallic dust is also created simply by forming and affixing the aluminum collar to the vial because aluminum dust is created in forming the aluminum collar, crimping of the collar and removal of the flip-off plastic cap. Aluminum collars have also been used to secure fluid transfersets on medicament vials. Transfersets may be utilized, for example, to transfer fluid from a syringe to a vial, such as to reconstitute a dry or powdered drug in a vial by adding a diluent or solvent. The reconstituted drug may then be withdrawn from the vial by the syringe. The inner surface of the transferset may be part of the drug fluid path and the aluminum collar or ring may bring aluminum particles in the sterile room where the drug is added to the vial or into the drug fluid path contaminating the drug. There have been attempts to reduce this problem by applying a coating to the aluminum cap or collar. Finally, the prior art also includes snap-on cup-shaped plastic caps or collars having a radially inwardly projecting end portion which is snapped over the rim portion of the vial. Snap-on plastic collars, however, do not assure adequate sealing of the vial or fully accommodate the tolerances of standard vials and stoppers as required.
The prior art also discloses plastic medicament vial transfersets. However, such plastic transfersets are relatively expensive having several interfitting parts and are difficult to use. The need therefore remains for a transferset for vials and other medical containers which may be utilized with conventional containers, such as medicament vials or cartridges, which assures sealing of the container and which achieves a good level of cleanliness, without particles or dust which may contaminate the medicament, the transferset or the clean room and which does not expose the healthcare worker to sharp metal edges. The need also remains for a transferset which may be easily secured to a vial or other medical container and which is relatively inexpensive, simple in construction and easy to use.
As set forth above, the improved transferset assembly of this invention may be utilized with conventional medicament vials and other medical containers to transfer fluids between the medical container and a second container such as a syringe. The transferset assembly of this invention eliminates the problems associated with malleable metal or aluminum collars, but accommodates the buildup of tolerances of the rim portion of the container and the elastomeric stopper. The transferset assembly of this invention is relatively simple in construction and may be formed of a malleable polymer which has sufficient rigidity to retain its shape following deformation and which is resistant to creep.
The preferred embodiment of the transferset assembly of this invention is adapted for attachment to a conventional medicament vial having an open end, a rim portion surrounding the open end and a reduced diameter neck portion adjacent the rim portion and wherein the open end of the vial is sealed with a conventional elastomeric stopper. The disclosed embodiment of the transferset assembly of this invention is also adapted for transferring fluids between a conventional syringe and a vial and may thus be utilized to reconstitute dry or powdered drugs stored in the vial by adding diluent or solvent to the vial with the syringe. As will be understood, however, the improved fluid transferset of this invention may also be used to transfer fluids between other types of containers, particularly medicament containers, and is therefore not limited in its use or application.
The transferset assembly of this invention includes an integral preferably polymeric transfer assembly including an outer tubular portion preferably having a radial end portion adapted to be connected to the vial or other container and an opposed free end, a cylindrical inner tubular portion spaced radially inwardly from, generally coaxially aligned with and preferably integrally joined to the outer tubular portion having a first end portion which is attached to the container in generally coaxial alignment with the open end of the container and adapted to sealingly engage the container having a free end. The assembly further includes a piercing member which is telescopically received in the inner tubular portion having a piercing end adapted to pierce a closure sealing the open end of the container and an opposed free end. In the most preferred embodiment of the transferset of this invention, the piercing member includes an axial passage including an enlarged intermediate chamber which receives a filter for filtering fluid received therethrough. In another disclosed embodiment, the piercing member includes an external open generally longitudinal channel providing fluid communication through the stopper or closure. As used herein, generally longitudinal means that the passage or channel transmits the fluid longitudinally and thus may include, for example, spiral channels.
Finally, the improved transferset assembly of this invention includes a removable closure sealing the opposed free ends of the inner and outer tubular portions of the transfer assembly sealing the container for later use. The most preferred embodiment of the closure is cup-shaped closure having frangible connectors in the rim portion providing a good seal and permitting easy removal of the closure. The rim of the cup-shaped closure includes an upper and lower portion with the upper and lower portions interconnected by frangible portions spaced circumferentially along the interface separating the two portions and the lower portion retaining the upper portion and the lid to the transferset until severance of the frangible portions. The frangible portions are angularly situated about the axis of the lid so they have some angular and radial strength but are easily compressible. In the disclosed embodiment, the frangible portions are pyramidal shaped and frangible so that the upper portion can be fractured or broken by either tilting or twisting the lid to remove it from the transferset. Further, severance of the frangible portions in response to initial separation of the upper and lower portions serves to provide integral and unmistakable evidence of tampering with the medical container and the medication contained therein. Further, the upper and lower portions include a plurality of paired spacer blocks preferably alternating with frangible portions. These pairs of spacer blocks are of trapezoidal shape and taper axially toward each other. The blocks partially bridge the gap formed between the spaced axial edges of the upper and lower portions and have outer ends that touch or are axially very closely juxtaposed with each other. The closure is fitted over the top of the transferset by simply axially pushing it until the projections deflect slightly and snap onto the transferset. During such installation, the blocks bear axially so that no significant force is transmitted through the frangible portions and consequently prevent braking of the frangible portions during assembly.
In the preferred embodiment of the transferset assembly which is adapted to transfer fluids between a conventional vial having an elastomeric stopper and a second container, the free end of the internal tubular portion includes a sharp edge that deforms the elastomeric stopper during assembly and provides a seal between the opening formed in the elastomeric stopper and the passage through the inner tubular portion. Further, the free end of the inner tubular portion includes an external Luer lock for threaded receipt of a syringe. The piercing member is releasably retained within the passage through the inner tubular portion by interlocking ribs, such that the piercing portion is adjacent or partially penetrates the planar portion of the elastomeric stopper. The free end of the piercing member is preferably generally spherical, such that the syringe engages the free end of the piercing member and drives the piercing portion through the planar portion of the elastomeric stopper. As set forth above, the preferred embodiment of the piercing member includes an axial passage, preferably including a filter. When the piercing end of the piercing member is driven through the planar portion of the elastomeric stopper, communication is provided through the piercing member and the inner tubular portion of the transfer assembly. Alternatively, where the piercing member includes an external generally longitudinal passage, the internal tubular portion of the transfer assembly provides fluid communication for transfer of fluids.
As described above, the transfer assembly of the transferset of this invention is preferably formed of polymer which is sufficiently malleable to permit radial deformation, yet sufficiently rigid to maintain its shape following deformation and resistant to creep. In the preferred embodiment of the transferset assembly of this invention, the integral polymeric transfer assembly includes a tubular collar portion which surrounds the planar portion of the elastomeric stopper and the rim of the vial or other medicament container having a free end which is deformed radially inwardly into the reduced diameter neck portion of the container to secure the transferset to the container. The free end may include an annular resilient ring retained to the internal surface adjacent the free end which prevents rotation of the tubular collar portion on the container.
In the most preferred embodiment of the transferset assembly of this invention, the integral transfer assembly is formed of a compost polymer including a polymer alloy or melt blend which includes a relatively tough soft malleable copolymer and a relatively rigid polymer. The composite polymer is most preferably a polymer alloy of a relatively soft, malleable copolymer and a relatively rigid polymer. The preferred relatively rigid polymer is a polyamide or polycarbonate and the preferred relatively soft copolymer may be selected from polyesters or polyolefins. The resultant polymer alloy or composite preferably has an elongation at yield between 5% and 10% and elongation at brake greater than 100% with a flexural modules of greater than 1900 MPa.
As set forth above, the transferset assembly of this invention may be utilized with a conventional medical vial or other medical container having a conventional elastomeric stopper. In the preferred embodiment of the transferset of this invention, the collar portion is integral with the coaxial tubular transfer assembly thus eliminating the requirement for malleable metal collars or caps, such as aluminum. The transferset assembly of this invention is relatively inexpensive and simple to manufacture, particularly when compared with transfersets having aluminum collars having protective metal coatings. The transferset assembly of this invention assures an excellent seal of the container and can be injection molded in a clean environment or washed, if necessary. Finally, the transferset assembly of this invention accommodates the tolerances of the vial and particularly the buildup of tolerance variations in the combination of a conventional vial and elastomeric stopper. Other advantages and meritorious features of the present invention will be more fully understood from the following description of the preferred embodiments, the appended claims and the drawings, a brief description of which follows.